EAS Consulting Group, LLC — EAS-e-NEWS — Current FDA Issues of Interest
A free monthly electronic newsletter published by EAS Consulting Group, LLC for the industries regulated by FDA.
Pharmaceuticals   ·   Medical Devices   ·   Foods   ·   Dietary Supplements   ·   Cosmetics
EAS Consulting Group, LLC · 1940 Duke Street, Suite 200; Alexandria, VA 22314 · (703) 684-4408
 August 2009
In this Issue:
Upcoming EAS Events
  • Schwemer Leads Bio/Pharma Risk Management Workshop [more]
  • Dietary Supplement GMP Seminar [more]
  • Ensuring Regulatory Compliance of Dietary Supplement Laboratories [more]
  • Food Labeling Seminar [more]
  • Food Labeling Update [more]
  • Dietary Supplement Labeling [more]

From the Desk of the President:
New Faces Signal Big Plans at FDA

Dear Reader:

Ed Steele, President Welcome to the August issue of EAS-e-News, our free monthly newsletter for industries regulated by the Food and Drug Administration. The agency was already picking up the pace since the arrival of its new top leadership. It has now taken on a new team of senior staffers to help implement ambitious plans for improving its food safety programs.

Michael Taylor, whose career has included terms as FDA Deputy Commissioner for Policy as well as Administrator of the USDA’s Food Safety and Inspection Service and Acting USDA Under Secretary for Food Safety, has rejoined the agency as an advisor to FDA Commissioner Margaret Hamburg.

Other prominent new additions at the agency include: Joseph Reardon, former director of the food and drug protection division of the North Carolina Department of Agriculture and Consumer Services; Jenny Scott, vice president of science policy for food protection at the Grocery Manufacturers Association; and James Gorny, a produce expert from the University of California–Davis.

Reardon will act as a liaison with the fifty states. Scott of GMA joins the agency as a senior advisor in the Center for Food Safety and Applied Nutrition. Gorny, a former chief food safety office with the United Fresh Produce Association who joined the University of California-Davis two years ago, is also joining FDA as a senior CFSAN advisor. He will act as a liaison to the produce industry.

Here at EAS, we have also added to our team of senior consultants, with the addition of Willie Bryant, a former senior recall officer at FDA, who is the author of our Issue of the Month article, titled “Why You Need a Recall Plan.” In addition, we have recently entered into a collaborative arrangement with Stericycle to serve our clients involved in recalls—or those who may be developing contingency plans for recalls (see details below).

We also welcome two other new team members, Nancy Chew and Len Steinborn, both of whom have extensive experience in the pharmaceuticals industry. This month’s EAS-e-News features an analysis by EAS Senior Consultant Norma Skolnik of the implications for OTC drugs of the recent acetaminophen recommendations by an FDA advisory panel.

As always, I hope you continue to find our “easy” updates informative and I encourage you to share the publication with your colleagues.

Best Regards,
Ed Steele Signature
Ed Steele,
President

Issue of the Month
Why You Need a Recall Plan
By EAS Senior Consultant Willie R. Bryant
In fiscal year 2008, FDA’s Center for Food Safety and Applied Nutrition classified 311 recall events which included a total of 610 products. Each event represents one individual food producer‘s recall, so we can assume that about 311 separate food manufacturers , repackers or distributors (primarily of imported products) conducted a recall of products falling under the CFSAN umbrella of foods, cosmetics, and dietary supplements. Of the 311 events, 176 were Class I, a potential life threatening or irreversible illness/injury situation. This fiscal year has found the trend continuing with peanuts, pistachios, and non-fat dry milk leading the march while recalls of products due to undeclared allergens and other potentially serious hazards continue at a fast pace as well.

Recalls can be devastating to a firm’s business, occasionally resulting in bankruptcy and cessation of business. At the least, they are disruptive to daily operations, result in negative press, and may damage the brand name as well as future sales of the recalled product. Recalls may result in loss in stock value and expensive liability cases.

Every manufacturer, repacker, distributor of products regulated by FDA can mitigate the damage from these unexpected, damaging events by having a Recall Plan in place. FDA industry guidance found in 21 CFR 7.59 states that a firm should “prepare and maintain a current written contingency plan for use in initiating and effecting a recall.” Ideally, all manufacturers of FDA regulated products would have a recall plan in place from its initial production and distribution; however, that is rarely the case, but any manufacturer without a recall plan should immediately initiate its’ development. Experience has shown that such a recall plan is critical to the timely and effective conduction of a recall.

A “Recall Team”

Having a comprehensive, up-to-date plan in place allows a recalling firm to expedite the notification to the public and to its consignees, thereby minimizing continuing risk to the public and limiting potential liability.

Depending on the size and management circumstances of the company, a “recall team” could include representatives from management, quality control, safety/medical, communications, regulatory, legal, marketing/sales, and distribution. A roster for immediate emergency contact should be established with backup persons identified where appropriate. Each team member needs to understand his/her responsibilities and to be prepared at all times to fulfill them. It often works best when one person is established as the “recall coordinator/manager” to pull together the team information, to keep top management informed, provide direction, and to serve as the spokesperson to the local FDA district office.

A thorough recall plan will manage publicity by having a recall communications plan set up to prepare and issue press releases, to handle press calls and consumer calls either through the firm’s own, or often third party, call center, and to manage immediate updates to the firm’s website. It is critical in this day of instant communication among the public, to control negative publicity as much as possible with having complete, thorough and honest communication.

One should keep in mind that FDA will most likely have an investigator in the firm at some point in the recall process, especially for a Class I recall. It is critical to the investigational process that you have thoroughly examined all avenues that could have resulted in the violative product. The FDA investigator’s primary responsibility during the inspection will be to “to determine the root cause(s) of the problem(s)” and to verify that all necessary steps have been taken to prevent recurrence of the problem.

Lastly, documentation of all aspects of the recall from notification, responses, effectiveness checks, returns, reported injury/illnesses, corrective actions, and disposition of the recalled product is necessary for FDA agreement to terminate your recall.

Who's Who at EAS:
Meet EAS Senior Consultant Willie Bryant

Willie Bryant Former FDA Senior Recall Officer Willie Bryant is working with the EAS consulting team as part of a new strategic alliance between EAS and Stericycle Inc. He has been a recall consultant since his retirement from the federal agency in 2004.

Mr. Bryant’s FDA career included nine years as an investigator, four years as recall coordinator in FDA’s Philadelphia district office, and 18 years as Recall and Emergency Coordinator at FDA headquarters in Rockville, MD.

In the ten years prior to his retirement, he was the Senior Recall Officer in the Office of Enforcement, Division of Compliance Management and Operations. In that role, he was responsible for providing day to day guidance and assistance to the 20 FDA district recall coordinators, providing liaison between the districts and the five FDA center recall teams, reviewing and clearing Class I recall recommendations to the Associate Commissioner for Regulatory Affairs, and assisting in the drafting of recall press by FDA or recalling firms.

In addition, he was the subject matter expert for the development of FDA’s Recall Enterprise System, the electronic communication system the agency uses to recommend, classify, monitor, and close recalls. He was responsible for numerous revisions of the FDA Regulatory Procedures Manual, Chapter 7–Recalls and was the primary author of the FDA’s Recall Guidance published in 2003. Since his retirement from FDA, he has been a consultant to Stericycle Inc. and its clients on various recall issues and has made numerous presentations at recall related conferences.

“EAS is fortunate to have Willie available to assist our clients with their recall needs. I am also delighted about the new alliance we have formed with Stericycle as we strive to add valuable new services for our clients,” says EAS President Ed Steele.

Implications for OTC Drugs of FDA Panel’s Acetaminophen Recommendations

By EAS Senior Consultant Norma Skolnik
The Food and Drug Administration is likely to require relabeling and reformulation of many OTC drugs containing acetaminophen – with new dose limits and stronger warnings – acting on the June 30 recommendations of an agency advisory panel. Although the agency is not obligated to follow the recommendations of its advisors, it usually does. And Dr. Sandra Kweder, deputy director of the Office of New Drugs at FDA’s Center for Drug Evaluation and Research has hinted strongly that the agency will probably follow the panel’s recommendations. FDA will keep the docket for the Advisory panel meeting open until Sept. 30, 2009 to receive comments.

The advisory group recommended that the maximum dose of over-the-counter painkillers with acetaminophen, such as Tylenol, Excedrin, and store brand drugs, should be lowered. The advice followed the release of an FDA report last month that found severe liver damage and even death can result from accidental overdose of products containing acetaminophen. The agency reported a lack of consumer awareness that acetaminophen can cause injury. Consumers may also not know that acetaminophen is present in many OTC drugs, including remedies for colds, headaches and fever, making it possible to exceed the recommended dose, the agency found. More than 400 individuals die and 42,000 are hospitalized each year from acetaminophen overdoses in the U.S.

The panel voted 24 to 13 that FDA should reduce the highest allowed dose of acetaminophen in OTC drugs like Tylenol to 650 mg. from the current 1000 mg. Members also voted to reduce the maximum daily dosage to less than 4000 mg. The panel voted to make the current 1,000 mg. dose available only by prescription.

The agency is also likely to limit children’s medicines containing acetaminophen to just one formulation. Currently the liquids are sold in two different concentrations, leading to parent confusion and potential overdose. This change would make it necessary for companies to reformulate and relabel many products. It is also possible that agency will require stronger warnings beyond the warnings required in FDA’s April 29, 2009 Final Rule, as well as new dosing directions on the product labels.
What's New on FDA's Website:

Listed below are links to new additions to the FDA website for the month of July, 2009. Use of this section of EAS-e-News is intended to provide an “easy” way to keep current with FDA news and information.

FDA Press Releases
Recalls and Safety Alerts
Congressional Testimony
Enforcement Reports
What's New by Topic
EAS in Action:
EAS Partners with Stericyle to Provide Expanded Recall Assistance

EAS Consulting Group has entered into a collaborative agreement with Stericycle, the leading provider of product recall and retrieval services. The alliance will offer EAS clients expanded recall assistance, providing them with a single source for planning and conducting product recalls.

The strategic partnership of EAS and Stericycle will provide firms in the food, dietary supplement, pharmaceutical, medical device and cosmetic industries with complete turnkey management solutions in planning, execution, reporting and termination of recalls.

“We are very pleased to announce this alliance, which will greatly enhance our services for clients in need of planning or assistance in conducting recalls,” says EAS President Ed Steele.

Stericyle, a publically held company with revenues in excess of $900 million, has performed more than 1,000 recalls/during the past two decades. it has been in business. They are the world leader in recalls.

EAS clients faced with recall issues can now not only have access to our FDA expertise, but can benefit from Stericycle’s technologies and resources, to notify, process, track and remove product from the marketplace as needed. If you have an urgent recall requirement, you can now tap into the expertise of both EAS and Stericycle.

Two Senior Consultants Join EAS Team

EAS Consulting Group has significantly increased its capacity to serve pharmaceuticals clients with the addition of Nancy Chew and Len Steinborn to the EAS team of senior consultants. Ms. Chew has been helping pharmaceuticals companies in bringing their products to market for more than 25 years. Mr. Steinborn has broad experience in the pharmaceutical, medical device, nutritional, API, and excipient industries.

Nancy Chew Ms. Chew is a frequent lecturer on regulatory issues and teaches courses in drug development and pharmaceutical registration. Early in her career, she worked with Hoffman-La Roche as a biochemist. She went on to found NJC Enterprises, a regulatory affairs and biomedical product development consultancy. In 1997, she founded Regulatory Affairs, North America LLC, a consulting consortium.

 
Len Steinborn Mr. Steinborn spent 20 years with Abbott Laboratories in Abbot Park, IL, where he had various management roles including that of manager of quality systems training and internal audit systems. In 2002, he joined AAC Consulting in Rockville, Md., as a senior consultant, where his work included GMP training at medical device facilities, review of non-conformance investigations and supplying guidance in corrective and preventive action to multiple facilities of a major pharmaceutical firm. Since 2006, he has worked as an independent consultant, providing a range of services including courses on GMP requirements and FDA inspection preparedness, as well as audits of drug, medical device and dietary supplement manufacturing operations. He is the author of the “GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers.”

“With their broad knowledge and expertise, Nancy and Len are valuable new assets for our clients,” says EAS President Ed Steele. “I am delighted to welcome them to the EAS team.”

Schwemer Leads Bio/Pharma Risk Management Workshop

EAS Senior Consultant Bill Schwemer will lead a pre-conference workshop on risk management at the upcoming 5th Annual Bio/Pharmaceutical and Medical Device Product Recalls Summit in Alexandria, Va., September 24-29, hosted by the Center for Business Intelligence.

The September 24 workshop will explore the most effective risk management models for bio/pharma companies, with a focus on practical applications. It will also review why the Food and Drug Administration is overhauling its risk assessment thinking.

James Wood, a partner at Reed Smith LLC, will be co-leader for the session. He recently co-authored a book titled “Prescription Product Recalls – A Proactive Primer.”

For more details, visit www.cbinet.com.

Take the GMP Challenge Quiz
Upcoming Events
New Food and Dietary Supplement Seminars

EAS has scheduled the following seminars for the coming months:

Dietary Supplement GMP Seminar
October 6-7, 2009
Alexandria VA

Ensuring Regulatory Compliance of Dietary Supplement Laboratories
October 8-9
Alexandria VA

Food Labeling Seminar
October 20-21
Alexandria, VA

Food Labeling Update
October 22
Alexandria, VA

Dietary Supplement Labeling
December 2-3
Alexandria, VA

Check the EAS web site for details.
Order Publications and Regulatory Tools

EAS Labeling Type Size Guide EAS Labeling Type Size Guide

A handy tool for measuring type size, package dimensions and line width on food, dietary supplement, cosmetic and OTC drug labels.		 $ 9.00
Code of Federal Regulations, A pocket Guide

Dietary Supplement GMP Regulation -
A Pocket Guide

A 4”x6” bound copy of 21 CFR Part 111 designed to fit in shirt pockets of management and plant personnel.

 < 25 $ 10.00 each
25-50 $ 9.00 each
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> 100 $ 7.00 each
Dietary Supplement Labeling Compliance Review, 3rd edition Dietary Supplement Labeling Compliance Review, 3rd edition

A valuable labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell

Hardbound book		 $ 184.99
Food Labeling Compliance Review, 4th edition Food Labeling Compliance Review, 4th edition

A valuable labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell.

Hardbound book and CD		 $ 209.99 / set
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